Mind Programme for Women With Breast Cancer
Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes
NA · University of Coimbra · NCT05642897
This study is testing a new program that combines mindfulness and therapy techniques to help women with breast cancer feel better and cope during and after their radiotherapy treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Coimbra (other) |
| Locations | 1 site (Coimbra) |
| Trial ID | NCT05642897 on ClinicalTrials.gov |
What this trial studies
This program integrates mindfulness, compassion-focused therapy, and acceptance and commitment therapy tailored for women with breast cancer. It aims to enhance psychological well-being, reduce distress, and support adaptation during and after radiotherapy treatment. The intervention builds on preliminary findings from a pilot study that indicated its acceptability and potential efficacy, although further testing with a larger sample and more rigorous methodology is needed.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-70 with a primary diagnosis of breast cancer (stages I to III) who are currently receiving radiotherapy.
Not a fit: Patients currently undergoing psychological interventions or those with severe psychiatric or neurological conditions may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the psychological health and overall well-being of women undergoing treatment for breast cancer.
How similar studies have performed: Preliminary findings from a pilot study suggest potential success, but further validation through larger studies is necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age between 18-70; 2. primary diagnosis of BC (stages between I and III); 3. undergoing radiotherapy treatment at CHUC; 4. able to understand and answer to self-report questionnaires in Portuguese. Exclusion Criteria: 1. currently undergoing any form of psychological intervention; 2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation; 3. diagnosis of neurological disease.
Where this trial is running
Coimbra
- Radiotherapy Service of the Coimbra University Hospital (CHUC) — Coimbra, Portugal (RECRUITING)
Study contacts
- Study coordinator: Inês A Trindade, PhD
- Email: ines.almeidatrindade@gmail.com
- Phone: 239851450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Female, Mindfulness, Compassion Focused Therapy, Acceptance and Commitment Therapy, biological markers, cost-effectiveness, mental health